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Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants
Sponsor: Shanghai Minwei Biotechnology Co., Ltd
Summary
This is a randomized, double-blind, placebo-controlled, Phase 1 clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetic (PK), and the effect of meal timing following single and multiple oral doses of MWN109 tablets in Chinese participants. The study consists of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part. The SAD part includes 6 dose cohorts, with further evaluation of the effects of different meal-timing conditions at a selected dose level. The MAD part includes 4 dose cohorts administered with once-daily or every-other-day dosing regimens for up to 4 weeks. Approximately 108 healthy participants aged 18 to 50 years are planned to be enrolled. The primary endpoint is safety, assessed by adverse events, serious adverse events, vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. The secondary endpoint is the pharmacokinetic characteristics.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Meal Timing Effects Following Single and Multiple Oral Administration of MWN109 Tablets in Chinese Study Participants
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
98
Start Date
2025-06-27
Completion Date
2025-12-20
Last Updated
2026-08-26
Healthy Volunteers
Yes
Conditions
Interventions
MWN109 tablet
A1, A2, A3a, A3b, A3c, A4; administered orally
MWN109 tablet
B1, B2, B3, B4; administered orally
Placebo
administered orally
Locations (1)
The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan, China